US Govt Accountability Office Recommends FDA and HHS Improve IRB Inspection Oversight

February 17, 2023

The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) received a rebuff from the Government Accountability Office (GAO) over their oversight over institutional review boards (IRBs) for clinical trials. IRBs, which help oversee ethics in research on the local level, are supposed to be overseen by the agencies, but in practice this rarely happens.

According to Katherine Lewin, “The issue with the current system, according to the GAO, is that “few” of the 2,300 US-based IRBs are inspected by the HHS and FDA each year. The agencies also lack self-reflection, the GAO says in its report — the agencies haven’t taken a look at themselves to see if they are doing the necessary number of inspections or if how inspections are done should be changed to reduce risks to patients during trials.”

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